藥物臨床試驗文件是記錄臨床試驗過程中所產(chǎn)生的所有信息、資料，反映研究者、申辦者和監(jiān)察員對GCP和所有的現(xiàn)行管理要求的依從性，并且作為藥品監(jiān)督管理部門進行監(jiān)察、新藥審批的第一手資料和關(guān)鍵依據(jù)。收集首都醫(yī)科大學(xué)附屬北京兒童醫(yī)院完成的和在研的藥物臨床試驗項目質(zhì)量控制中文檔管理中發(fā)現(xiàn)的問題，采用回顧性分析方法，對存在的問題進行歸類，結(jié)合我機構(gòu)對藥物臨床試驗質(zhì)量控制經(jīng)驗歸納出檔案管理的要求，完善藥物臨床試驗質(zhì)量控制的全過程管理。

The clinical trial document contains all information and data in the clinical trial process,reflecting the compliance of the researchers, the sponsor and CRA to the GCP and all existing regulatory requirements, as the first hand information and key basis for the supervision and approval of the drug administration department. This paper collected from document management problems found by the retrospective analysis method, combined with my agency for quality control of drug clinical trials experience summing up the requirements of archives management, improve the whole process of drug clinical trials quality control management.